ClearumTM HS Dialyzers

Explore the benefits

Safety

Biocompatibility

  • BPA-free materials and process.

Hemocompatibility

  • Steam sterilization ensures a lower impact on various indices from WBC, platelet count, level of C3a, C5a and PMN elastase.1

Endotoxin Barrier

  • The Clearum™ HS performs as a barrier, minimizing the transfer of pyrogens into the patient’s bloodstream in case of backfiltration.*,2 This can prevent potential patient side effects such as inflammation and the release of cytokines.

Performance

In vitro1,2 and vivo3 data shows that ClearumTM HS Dialyzers membrane eliminates the smaller toxins in an effective way, regularly removing the larger toxins, and at the same time, preserving the nutrients and proteins like albumin.

All this thanks to packing density, fiber thickness, undulation, pore size distribution, selected diffusive permeability and water permeability.1,2

The undulation of the capillaries and a balanced packing density allows ClearumTM HS Dialyzers to foster diffusion mechanism.

The membrane of the Clearum™️ HS Dialyzers, thanks to its sieving coefficient, shows a good tendency in preserving albumin to the patient, keeping a safe approach.1

Usability

Results from Limited Controlled Distribution (LCD) evaluating blood rest, packaging, priming and handling through two user experience questionnaires, rating the dialyzer at the end of each treatment.4

6 Centers across 4 countries, 65 patients during 612 treatments using 8 monitors were included in this LCD.

90%

Priming

Users showed a good acceptance level (about 90%) of ClearumTM HS Dialyzers in priming procedures, using Medtronic machines.

Fresenius - 5008: 96.6%
Nikkiso - DBB EXA: 99.4%

100%

Packaging

The 100% of the users interviewed showed good acceptance for both the primary and the secondary packaging.

73%

Blood rest

Users showed a good acceptance level (>70%) of ClearumTM HS Dialyzers in the blood rest procedures using Medtronic machines.

100%

Handling

Users showed good acceptance considering ClearumTM HS Dialyzers overall easy to connect not only to Medtronic bloodlines, but also with the competitor ones.

Sustainability

Lower CO2 emission

  • Polypropylene material reduces the carbon footprint by 60%.5

Water Recovery

  • 95% of the water and solvent can be recovered and recycled.6

No ozone release

  • Steam sterilization process avoids releasing ozone material.7

References

      * Based on internal test report # TR_END_001_R00 Clearum Endotoxin Retention Test Report
 
  1. TR_SIE_007_R02_Clearum Sieving Coefficient Test Report
  2. TR_CLE_008_R02_Clearum Clearance Test Report
  3. Maduell F, Broseta JJ, Guillen MA, et al. Efficacy and Safety of the Clearum Dialyzer. Artif Organs. 2021;45(10):1195-1201.
  4. Clearum™ HS Series LCD Report_Rev00
  5. Keoleian G, Miller S, De Kleine R, Fang A, Mosley J. Life Cycle Material Data Update for GREET Model. University of Michigan: Ann Arbor. 2012:1-74Efficiency of recovery for solvent and water in CLEARUM GmbH, (Sept 2nd - 2019)
  6. Efficiency of recovery for solvent and water in CLEARUM GmbH, (Sept 2nd-2019)
  7. GIPA-IIA, 2017, A comparison of gamma, e-beam, x-ray and ethylene oxide technologies for the industrial sterilization of medical devices and healthcare products